Senior II, Packaging Process Engineer

Arthrex, Inc. is a global medical device company and a leader in new product development and medical education in orthopedics.  Arthrex is currently seeking a Senior II, Packaging Process Engineer. The Senior II, Packaging Process Engineer will provide packaging process engineering support to AMI Packaging Operations and INC Packaging Design teams to achieve business goals.  To lead projects involving: rapid commercialization of new products; commercialization of new equipment; improvements to equipment; data collection; process performance improvements; increases in productivity and production capacity; and ongoing reduction of costs. Join our talented team at a global medical device company focused on Helping Surgeons Treat Their Patients Better™, located at our Ave Maria, FL manufacturing site.

Essential Duties and Responsibilities:

• Support new product development/design transfer by leading Packaging Material process development and validation. 
• Develop and support a continuous improvement culture to enhance quality, operational excellence, and cost.
• Develop and maintain Master Validation Strategies and Master Validation Plans for packaging/sealing/inspection processes.
• Draft and execute validation protocols and reports (IQ,OQ/PQ) for various packaging and labeling processes including: pouch sealing (impulse, continuous band, vacuum, vacuum+nitrogen flush); blister tray sealing (standard and vacuum+nitrogen flush); label print/apply systems; laser ablation; die cutting; blister thermoforming.
• Lead the design, development, and commericialization of new equipment including: gathering user requirements, designing equipment mechanical and electrical systems, developing equipment specifications, coordinating quotes and procurement of new equipment with vendors, validation, work instruction development, BOM and Router management, and training of operations.
• Maintain certification and management of the ISTA-certified Packaging Test Lab.  Coordinate testing assignments to maintain lab Turn-Around-Time goals.
• Perform and train technicians and engineers on packaging test methods including: distribution testing, accelerated aging, burst testing, peel testing, dye penetration testing, and bubble emission testing.
• Develop, validate packaging test methods including new test equipment, new tooling/fixturing in response to industry changes or to provide additional capabilities in the test lab or in operations.
• Confers with vendors to determine product specifications and arrange for purchase of equipment, materials, or parts, and evaluates products according to specifications and quality standards.
• Design, develop, and manage tooling and fixtures.  Coordinate quotes and procurement of new tooling with vendors.  Assess and execute validation requirements accordingly.
• Lead the commericialization of new packaging sealing equipment including: developing equipment specifications, coordinating quotes and procuremet of new equipment with vendors, validation, and training of operations.
• Support the maintenance of equipment and tooling once released to production through troubleshooting, repair tracking, and analysis of impact to the validated state.
• Develop an understanding of current manufacturing processes and identify targets for improvement in data collection/trending, work order transaction processes, and operational efficiencies.
• Design, develop, and manage packaging/sealing tooling and fixtures and related validation activities.  Coordinate quotes and procurement of new tooling with vendors.
• Ensure data and documentation are consistently accurate and complete including Work Instructions, Setup Sheets, BOMs and Routers.
• Applies statistical methods to estimate future manufacturing requirements and potential.  Develop sampling procedures, forms, and instructions for recording, evaluating, and reporting quality and reliability data.
• Analyzes and plans workforce utilization, space requirements, and workflow, and designs layout of equipment and workspace for maximum efficiency utilizing lean techniqies when feasible.
• Estimates production times, staffing requirements, and related costs to provide information for management decisions.
• May supervise Technician, Engineering, Prototype or Programming personnel.
• Remain current with ISO/FDA/ASTM/ISTA standards and internal quality assurance policies.  Support Audits as the packaging/sealing subject matter expert.

Knowledge

Complete understanding and application of principles, concepts, practices, and standards.  Full knowledge of industry practices and regulations.

Reasoning Ability

Develops solutions to a variety of complex problems.  May refer to established precedents and policies.

Discretion/ Latitude

Work is performed without appreciable direction.  Participates in determining objectives of assignments.  Plans, schedules, and arranges own activities and direct reports and team resources to accomplish objectives.  Work is reviewed upon completion for adequacy in meeting objectives. 

Skills

• Advanced knowledge of applicable medical device Packaging Material options, converting processes, and Heat-Sealing Processes and related tooling design.
• Advanced understanding of all relevant manufacturing processes and interdependencies.
• Keeps informed on emerging technologies and recommends process improvements accordingly.
• Proficiency in Industry Standards (ASTM, ISTA) Packaging Test Methods.
• Proficiency in compliance with ISO regulations and FDA 21 CFR Part 820.
• Advanced CAD software skills required.
• Proficiency in developing new Master Validation Strategies for Packaging Processes in compliance with industry, regulatory, and internal quality standards.
• Proficiency in drafting and executing complex engineering study protocols, DOE’s, analyzing data, managing and resolving deviations and writing reports.
• Proficiency in using project management tools (MS Project, Mindview, Workfront) to plan and track projects.
• Proficiency in preparing complex capital equipment proposals including cost analysis and justification (ROI).
• Ability to proactively communicate ideas, results, recommendations, and status effectively in oral and written forms.
• Ability to directly supervise junior level engineers, contractors, and technicians.
• Ability to innovate new design solutions to improve existing equipment and systems.

Education/Experience

• B.S. in Engineering required; preferably in Packaging Engineering.
• Minimum of 8 Yrs. experience in Packaging Design and Development or relevant Manufacturing required.
• Proven Experience leading process improvement projects.
• Proven Experience leading new equipment, capital projects.
• Experience in medical device manufacturing or other health sciences industry preferred.
• Experience working in a Cleanroom environment preferred.
• SAP, miniTab, Solidworks experience required.
• Lean Six Sigma Green Belt / Black Belt certification preferred.

Reasoning Ability:

Ability to define problems, collects data, establish facts, and draw valid conclusions.  Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.

Mathematical Skills

Ability to comprehend and apply mathematical principles to the degree required to perform the job based upon job requirements. 

Language and Communication Skills:

Ability to comprehend and apply language skills to the degree required to perform the job based upon the job requirements listed above.  Ability to verbally communicate ideas and issues effectively to other team members and management.  Ability to write and record data and information as required by procedures.

Physical Demands:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of the job.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.  While performing the duties of this job, the employee is regularly required to talk or hear. 

The employee is frequently required to stand for 8-10 hours per day wearing gowns, hairnets, and gloves; use hands and fingers, to handle, or feel; and reach with hands and arms.  The employee must frequently lift and/or move up to 20 pounds.  Must possess the dexterity to utilize writing utensils (pen/pencil), calculators, small hand-held tools, manual razors, and other mechanical/electrical equipment without assistance.  Ability to work in close proximity to fellow teammates in cramped conditions.

Vision Requirements:

Visual acuity necessary to do the job safely and effectively. 

Specific vision abilities required by this job include close vision using a microscope and light source

Work Environment:

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.  The area that this job is performed in is a general office or open cubicle/workstation environment.  The noise level in the work environment is usually moderate.

Arthrex 2023 Benefits

• Medical, Dental and Vision Insurance
• Company-Provided Life Insurance
• Voluntary Life Insurance
• Flexible Spending Account (FSA)
• Supplemental Insurance Plans (Accident, Cancer, Hospital, Critical Illness)
• Matching 401(k) Retirement Plan
• Annual Bonus
• Wellness Incentive Program
• Free Onsite Medical Clinics
• Free Onsite Lunch
• Tuition Reimbursement Program
• Trip of a Lifetime
• Paid Parental Leave
• Paid Time Off
• Volunteer PTO
• Employee Assistance Provider (EAP)

All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.